Surgical suturing device

ABSTRACT

A mechanical apparatus for suturing biological tissue, or ligating a biological tube or duct, in remote or otherwise inaccessible areas such as internal body cavities. The suturing apparatus includes an elongated housing, a head assembly pivotally mounted to the elongated housing capable of independent articulation, a continuous loop belt mounted within the elongated housing and head assembly for circulation therein, an arcuate needle mounted in the head for 360° rotation having a plurality of projecting means for engaging the continuous loop belt, means for articulating the head assembly from a position outside a patient&#39;s body, and means for circulating the continuous loop drive belt. A kit for suturing biological tissue, or ligating a biological tube or duct, comprising a cannula and a mechanical apparatus for suturing or ligating as described above, configured and dimensioned to be slidingly received in the cannula.

TECHNICAL FIELD

The present invention generally relates to surgical instruments, andmore particularly, to suturing devices.

BACKGROUND OF THE INVENTION

Various forms of suturing devices are known in the art, and those whichutilize a curved needle are particularly relevant to the presentinvention. For example, U.S. Pat. Nos. 4,027,608 and 4,235,177 toArbuckle, 4,406,237 to Eguchi et al., 4,417,532 to Yasukata, and4,440,171 to Nomoto et al. describe suturing devices that use areciprocating curved needle and means for looping and/or securing asuture thread; U.S. Pat. No. 4,557,265 to Andersson, describes asuturing device and method for moving an arcuate needle in a closed paththrough opposite edges of a tissue incision to complete a suture; U.S.Pat. No. 4,899,746 to Brunk describes a suturing device incorporating acurved needle into a motor driven cassette; and, U.K. Patent No. 18,602to Mitchell describes a suturing device utilizing an arcuate needlehaving two recesses on remote ends of the needle which are capable ofbeing engaged by two mating tooth-like projections on the surface of aband.

There are various drawbacks, however, with the prior art. For instance,the apparatuses described in Arbuckle, Eguchi, Yasukata and Nomoto use areciprocating needle. These devices therefore require an added mechanismfor looping and/or securing the suture thread. The added mechanism,however, unnecessarily increases the size of the suturing device makingit impractical for suturing in small or crowded areas, such as, internalbody cavities. Notwithstanding that problem, the added mechanism is alsoless efficient for tying a suture knot when compared to thesemi-automatic knot tying capabilities of the present invention.

There are prior art devices which do not require the added threadlooping mechanism. In general, these devices utilize a fully rotatingarcuate needle. These instruments, however, pose a potential health riskto surgery patients. For instance, instruments as described in Anderssonand Brunk both utilize friction rollers to drive a curved suturingneedle through biological tissue. The suturing needle, however, does notpositively engage the friction rollers (and vice versa), and therefore,the needle is not prevented from slipping and embedding in a patient.This most likely occurs when the needle encounters a friction force fromthe tissue being sutured greater than the friction force of the rollersdriving the needle. Needle slippage can be avoided by ensuring positiveengagement of the needle with a driving mechanism like the apparatusdescribed in Mitchell. However, even the Mitchell apparatus, poses thesame risk of embedding the needle in a patient where either tooth on theband fails to engage with its sole mating recess on the needle.Therefore, as evidenced by the prior art, there is a need for a suturingapparatus which overcomes these apparent problems.

Also known in the art are suturing instruments for arthroscopic surgery,laparoscopic procedures, and other small-scale surgical applications.For example, U.S. Pat. Nos. 1,822,330 to Ainslie, 3,871,379 to Clarke,4,597,390 and 4,621,640 to Mulhollan et al., 4,781,190 to Lee, 4,923,461and 4,957,498 to Caspari et al., 5,047,039 to Avant et al., and5,059,201 to Asnis describe devices related to these medical procedures.None of these devices, however, utilize an arcuate suturing needle. As aresult, these devices are bulkier, less efficient and less accurate forperforming such procedures than the present invention described herein.

SUMMARY OF THE INVENTION

In light of the aforementioned drawbacks with the prior art, it is aparticular objective of this invention to prevent the suture needle fromslipping. To achieve this objective the present invention comprises abody member wherein there is a continuous loop belt mounted forcirculation, and an arcuate needle mounted for 360° rotation, having aplurality of spaced projecting means for positively engaging the belt.At least two of the projecting means engage the belt at all times. Bysatisfying the present objective the present invention is an improvementover prior art instruments for suturing biological tissue, or ligating abiological tube or duct.

Because the needle advances through its suturing rotation when the drivebelt passes over the needle, the body member also contains means forcirculating the continuous loop belt. The means for circulating the beltincludes an engine and a coupler. The engine has a reciprocating pistonslideably mounted within a cylinder which transforms a flow of pressurefluid (into the cylinder) into compression of a spring. Driving force issupplied by the release of the compressed spring. The coupler comprisesan elongated coupling sleeve having a plurality of projecting means forengaging the drive belt. This allows the drive belt to be connected tothe engine, and more specifically, to the compressed spring.

An additional objective of the present invention is to provide asuturing apparatus that allows for suturing or ligating in remotelocations or otherwise inaccessible areas, such as internal bodycavities. To satisfy this objective, the body member of the presentinvention comprises an elongated housing and a head assembly. The headassembly is mounted on the end of the elongated housing and is capableof independent articulation from the housing, as described below.Additionally, the present invention uses a fully rotating arcuateneedle. Therefore, a suture knot can be semi-automatically tied byprearranging the suture thread on the head assembly before suturing,followed by simple manual manipulation of the ligature material afterthe thread has been installed in the biological tissue. This eliminatesthe need for an additional looping mechanism (associated withreciprocating needle devices) and further decreases the size of thepresent invention. As a result of these refinements, the suturinginstrument described herein is dimensioned and configured to be insertedthrough a trocar cannula which has been previously inserted into aninternal body cavity of a patient.

It is a further object of the present invention to enable a user toposition the head assembly (containing the suture needle) from alocation outside a patient's body, even when the suturing device isinserted within an internal cavity of a patient. The present inventionsatisfies this objective by pivotally mounting the head assembly to theelongated housing for independent articulation. A plurality ofsprocketed belts provides means for articulating the head assembly andneedle contained therein.

An additional object of the present invention is to provide a kit forsuturing biological tissue or agating a biological tube or duct. The kitincludes a sealed container filled with a lubricating substance, atrocar including a cannula adapted to sealingly receive a stylet (alsoincluded) and the suturing device as described herein, configured anddimensioned to be inserted into the cannula.

An added benefit of the present invention is that it reduces a patient'stime for recovery by limiting the cutting and carnage of the patient'sbody associated with internal surgical procedures. For instance, aninternal abdominal operation merely requires a surgeon to insert thesuturing apparatus described herein through a cannula located in thepatient's abdominal wall. The surgeon can observe the area to be suturedor ligated through a viewing device inserted through another cannula.Other operating tools can be similarly inserted into the body cavity.This arrangement eliminates cutting open the patient's abdomen, andultimately reduces the patient's time for recovery.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an overall perspective view of the surgical suturing device ofthe present invention;

FIG. 2 is a partial front view of the saddle and the barbed arcuatesuturing needle located within the head of the surgical suturing device;

FIG. 3 is a partial cross-sectional side view of the saddle and thebarbed arcuate suturing needle taken along line 3--3 of FIG. 2 and alsodepicting the needle drive belt engaged with the needle;

FIG. 4 is a side view of the saddle and barbed arcuate suturing needlethat is located within the head of the surgical suturing device;

FIG. 5 is a view similar to FIG. 2, except that it shows the barbedarcuate suturing needle rotated partially out of the saddle;

FIG. 6 is a front end view of the head (proximal end) of the surgicalsuturing device according to the invention;

FIG. 7 is a partial plan view of the head of the surgical suturingcatheter;

FIG. 8 is a partially sectioned side view of the head of the surgicalsuturing device;

FIG. 9 is a partially sectioned side view of the head (having a completeside view of the saddle) of the surgical suturing device taken alongline 9--9 of FIG. 7;

FIG. 10 is an exploded view of the surgical suturing device of thepresent invention with the outer body member removed;

FIG. 11 is a sectional top view of the distal end of the surgicalsuturing device taken along line 11--11 of FIG. 1;

FIG. 12 is a sectional side view of the distal end of the surgicalsuturing device taken along line 12--12 of FIG. 1;

FIG. 13 is a sectional side view of the surgical suturing device, takenalong line 13--13 of FIG. 1, showing the engine before compression ofthe spring;

FIG. 14 is a view similar to FIG. 13, except that it depicts the engineafter compression of the spring;

FIG. 15 is a partial section view taken along line 15--15 of FIG. 13,showing the follower and the detent plate;

FIG. 16 is a cross-sectional view through the coupler of the surgicalsuturing device, taken along line 16--16 of FIG. 13, before the drivebelt is coupled to the engine;

FIG. 17 is a view similar to FIG. 16, except that it depicts the couplerafter the drive belt is coupled to the engine;

FIG. 18 is a schematic sectional view illustrating the movement ofcertain features of the coupler (as shown in FIG. 11) as the coupler isactivated; and

FIG. 19 is similar to FIG. 18, except that it illustrates movement ofcertain features of the coupler as the coupler is deactivated;

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to FIG. 1, surgical suturing device 1 has four basic sections:a head 2, an engine 6, a coupler 7, and a drive belt management/headarticulation section 8. These four sections are aligned such thatsuturing device 1 can be inserted S into a cannula 4 of a known trocar,such as described in U.S. Pat. No. 4,177,814 which is incorporatedherein by reference thereto. This permits a user of suturing device 1 toperform suturing procedures inside a patient's internal cavities, or inother remote locations.

It is to be understood that moving parts described and illustrated havesufficient clearance to move relative to an adjacent part withoutincurring unwanted friction or seizing therebetween. This isparticularly relevant to the figures where several adjacent moving partsare depicted as touching one another for the sake of clarity in thedrawings.

Referring to FIGS. 2-5, suturing device 1 installs a suture by rotatingan arcuate suturing needle 5 through biological tissue to be sutured.Arcuate suturing needle 5 is mounted for 360° rotation within head 2,and preferably has a three-edge cutting point, although alternativeshapes are possible. The needle is preferably made of stainless steel,however, many a variety of surgical grade materials may be used as willbe appreciated by those skilled in the art. Needle 5 also has a seriesof radially outward projecting barbs 11, which are angled, preferablyacutely, to the rear (trailing thread end) of needle 5. These barbs 11are formed either at least substantially around the outer perimeter ofthe needle, or in groups around the perimeter. The angle of barbs 11facilitates engagement of needle 5 with a needle drive belt 12 whichpasses over needle 5 in the direction of the needle's leading point.This causes the needle 5 to rotate when the belt 12 is moved forward.Although needle barbs 11 penetrate belt 12 they are oriented to passfreely through any biological tissue to be sutured. Preferably, thebarbs are closely spaced and positioned such that at least two barbscontact the belt at all times during rotation of the needle to ensureconstant positive engagement between the needle and the belt.

As needle 5 rotates, it is supported on a semi-circular saddle 13.Saddle 13 extends around an arc of slightly more than 180° so needle 5,which also extends around an arc of more than 180°, is always in slidingcontact with the saddle. Referring to FIGS. 3 and 9, saddle 13 is slopedinward towards a needle guide groove 15 formed in the saddle along itscircumference. Groove 15 ensures that needle 5 is retained in the saddleas it travels through its arcuate path. Preferably, groove 15 is thesame shape as the cross-sectional shape of needle 5, allowing needle 5to fit snugly into the groove. As best seen in FIGS. 3 and 9, groove 15is triangular in shape to match the preferred triangular shape of needle5.

Referring to FIGS. 3 and 4, saddle 13 is supported on mounting post 14which extends perpendicularly from saddle 13. Preferably, post 14 isrectangular in shape (although any shape compatible with the design ofhead 2 can be used) and can be either riveted or cemented within head 2.Alternatively, post 14 can be screwed into or otherwise temporarilysecured to head 2 if a removable saddle 13 is preferred; for instance,to facilitate changing or loading a new needle 5 by allowing the needleto be placed directly on saddle 13, as described below.

Referring back to FIGS. 2-5, as needle 5 rotates it passes acrossopening 16 formed in the lower portion of the saddle on the oppositeside of where the needle and saddle mate. Opening 16 accommodatesbiological tissue to be sutured. Needle 5 reenters saddle 13 at needleentrance 17 which is designed to funnel needle 5 back into groove 15. Bymaintaining needle 5 in needle guide groove 15, control and accuratepositioning of needle 5 can be preserved, regardless of the forcesencountered by the needle as it passes across opening 16 and through anybiological tissue to be sutured.

Referring to FIGS. 6-8 and 10, needle 5 rotates across opening 16 whencontinuous loop needle drive belt 12 passes over and engages needle 5within head 2. Needle drive belt 12 is made of a flexible yet stretchresistant composite of materials having a pliable, tear resistantexterior which is penetratable by barbs 11, and a strong non-elasticcore. The belt can be constructed of a variety of materials whichsatisfy the foregoing characteristics and are appreciated by thoseskilled in the art. Preferably belt 12 has a square cross-sectionalshape, although it can be circular, elliptical, rectangular, or almostany shape which is compatible with the suturing device's internalmechanism.

Circulation of drive belt 12 through head 2 is directed by pulleys18-21, and flanges 22 and 23 (see FIG. 10). Pulleys 18 and 21 arerotatably mounted on axles 26 and 29, respectively. Pulleys 19 and 20,as well as flanges 22 and 23, are rotatably mounted on axles 27 and 28,respectively. As belt 12 enters head 2, belt 12 engages pulley 18.Pulley 18 redirects belt 12 under pulley 19, whereby the belt makes a180° turn and is redirected over needle 5. Flange 22 facilitatesengagement of belt 12 with needle barbs 11 by pressing the belt 12against the needle barbs near needle entrance 17. Front wall 24 and rearwall 25 of device 1 (see FIG. 8) maintain belt 12 over needle 5 as thebelt extends over, and is engaged with, the needle sliding on saddle 13.As belt 12 disengages from needle barbs 11, belt 12 encounters a secondflange 23 (FIG. 6), which helps maintain belt 12 on pulley 20 as itpasses therearound. Belt 12 passes under pulley 20, up and over pulley21, before exiting head 2 and passing down the length of suturing device1.

In the preferred embodiment illustrated in the drawings, needle 5 liesin a plane which is essentially perpendicular to the plane in whichpulleys 18-21 lie. In order to minimize the cross-sectional area of head2 it is contemplated, in an alternative embodiment, that needle 5 andpulleys 18-21 may lie in the same or parallel planes.

As shown in FIGS. 8 and 10, drive belt 12 is directed through theremainder of device 1 by pulleys 30-33, and raised surfaces 34 and 35.Referring to FIGS. 7, 8 and 10, as drive belt 12 exits head 2 it engagespulley 30 and then crosses itself between pulleys 30 and 31. Pulleys 30and 31 are rotatably mounted on axles 51 and 41, respectively. Afterpulley 31, belt 12 encounters two protruding surfaces 34 and 35 whichstabilize belt 12 as it extends down the length of suturing device 1.Protruding surfaces 34 and 35, in conjunction with raised partition 35A,are preferably spaced to form a gas-tight seal around belt 12 (and belts45 and 59). This restricts the escape of gases or pressure in the bodycavity, through the body of suturing device 1, during suturingprocedures. Similar provisions are taken to seal the passagesaccommodating belts 45 and 59.

Referring to FIGS. 10, 11 and 12, as belt 12 approaches the proximal endof device 1 it initially engages pulley 32 before crossing itself againbetween pulleys 32 and 33. Pulleys 32 and 33 are rotatably mounted onaxles 42 and 43, respectively, which in turn are mounted on a carriage36, which is explained below. Pulley 32 facilitates engagement of belt12 with pulley 33 by maintaining the belt within flanges 39 formed onthe outer circumference of pulley 33. As best shown in FIGS. 1 and 11,pulley 33 is larger than the other pulleys utilized in the drive beltmanagement system, and extends outside of housing 3. This allows belt 12to be gripped directly by a user as a manual control for positioningneedle 5 in saddle 13.

Referring again to FIGS. 10, 11 and 12, carriage 36 is slideably mountedin housing 3, and further secured to the housing by tension spring 37.The primary purpose of spring 37 is to bias the carriage and the pulleysin the proximal direction and thus ensure a constant tension in belt 12.Maintaining a constant tension in the belt eliminates slack and preventsit from dragging on the inside surface of housing 3, which would hinderthe belt's movement. More importantly, the application of constanttension facilitates proper engagement of belt 12 with needle barbs 11 onneedle 5 in the area over saddle 13 at the distal end of device 1. Inorder to temporarily relieve tension on belt 12, for example, when a newneedle 5 is installed, carriage 36 can be slid forward by pushing pulley33 distally. The carriage is temporarily secured on latch 38 with arm36A received in notch 38A. A lever 38B is provided in the top portion ofhousing 3 which forces latch 38 downward and releases arm 36A from notch38A when the lever is depressed (FIG. 12).

Referring to FIGS. 3 and 4, changing or loading a new needle 5 intosaddle 13 is accomplished by placing the needle on loading surface 13Awith the leading point of the needle facing needle entrance 17. Whilemaintaining needle 5 essentially on surface 13A, the leading point ofneedle 5 must be manually directed into needle entrance 17 as belt 12 ismanually rotated. Continuous operation of the belt will carry needle 5completely onto saddle 13 after which the proper starting position ofthe needle can be ascertained. Alternatively, saddle 13, supported onpost 14, can be designed such that it is removable from head 2. Thiswould allow needle 5 to be placed directly on saddle 13 which can thenbe reattached to head 2 ready for use.

As explained above, needle 5 engages belt 12 and is advanced through a360° suturing rotation by movement of belt 12 through the suturingdevice. In order to advance the belt automatically, engine 6 is providedin housing 3 slightly distally of the midpoint of the device 1 (see FIG.1).

Referring specifically to FIGS. 13 and 14, it can be seen that engine 6is mounted inside housing 3 between two bulkheads 61 and 97. The engineis activated by fluid pressure. Any medically suitable lubricating fluidmay be used as a hydraulic medium. The pressure fluid is provided to theengine by depressing a foot operated pump (not shown) that is connectedto the engine by a single small diameter hydraulic tube 62. The designof such a device is within the ability of persons skilled in the art.

Tube 62 communicates with engine 6 through opening 64 located in theproximal end of cylinder 65. Cylinder 65 is lined with a rollingdiaphragm 66 which is fixed at opening 64 to cylinder 65. Rollingdiaphragm 66 extends from opening 64 into the open cavity of cylinder 65and folds back upon itself between the inner wall of cylinder 65 and theouter wall of piston 67. Rolling diaphragm 66 is fixed at its other endto the proximal end of piston 67 at connection point 68. Rollingdiaphragm 66 not only contains the flow of hydraulic pressure fluid 63emitted into cylinder 65, but also allows piston 67 to reciprocatewithin the cylinder. For orientation it should be appreciated that thepiston-cylinder arrangement is disposed substantially within couplingsleeve 78. Coupling sleeve 78 forms part of coupler 7, which couples theengine to drive belt 12. The coupler and sleeve are explained in detailbelow.

As shown in FIG. 13, engine 6, and more specifically, spring 69 areshown in a prespring compression stage. Compression of the spring (asshown FIG. 14) is accomplished by the arrangement of piston 67, a thrustbearing 96, a connecting rod 71, a connecting rod shoulder enlargement75, and two spring bushings 76 and 77. Pressure applied to piston 67, bythe flow of pressure fluid 63 into cylinder 65 (as described above),forces the piston to move distally within the cylinder. Movement ofpiston 67 is transmitted to connecting rod 71 through thrust bearing 96.Near the center of connecting rod 71 is a shoulder enlargement 75 whichtransfers movement of connecting rod 71 to spring bushing 76 slideablymounted on the connecting rod. Mounted on a shoulder formed on bushing76 is the proximal end of spring 69. The distal end of spring 69 islikewise mounted on a shoulder of a second spring bushing 77 which isheld stationary against the proximal end of an engine housing 73.Therefore, as shown in FIG. 14, as fluid pressure is applied to engine6, movement of connecting rod 71 and shoulder enlargement 75 istransmitted to spring bushing 76 which compresses spring 69 againstbushing 77, until both bushings come into contact with one another.

The work of compressed spring 69 is converted into rotation of needle 5by coupler 7. During the spring compression cycle, movement ofconnecting rod 71 actuates coupler 7 to engage drive belt 12 just as thespring reaches its compressed state (as shown in FIG. 14). Therefore,when fluid pressure is suitably reduced in cylinder 65 (by the releaseof foot pedal pressure), the engine begins its power stroke with spring69 extending and drive belt 12 drawn forward by the spring throughcoupler 7. As described above, movement of drive belt 12 causes needle 5to move through its suturing rotation.

Referring to FIGS. 11 and 13, coupler 7 engages drive belt 12 throughcoupling sleeve 78 provided with toothed belt engaging tabs 88 and 89.Coupling sleeve 78 is keyed to the translational movement of connectingrod 71 by an inward directed flange 79 (FIG. 13) fitted within anannular space between bushing 76 and shoulder enlargement 75. However,flange 79 has sufficient clearance 79A from connecting rod 71 to allowthe sleeve to rotate freely. Rotation of sleeve 78 allows the toothedtabs 88 and 89 to engage and disengage drive belt 12 during the variouscycles of engine 6 as explained below.

Rotation of sleeve 78, in response to linear motion of connecting rod71, is created by an arrangement of guiding tabs and posts and anelastic band. The general location of tab 83, posts 84 and 87, rail 85and band 86 can be seen, for example, in FIGS. 11 and 16.

Referring specifically to FIGS. 18 and 19, the operation of thisarrangement is explained in detail. Before pressure is applied to spring69 in engine 6, outwardly directed tab 83, located on the outsidesurface of coupling sleeve 78, rests against post 84, mounted on theinside surface of the housing 3 (FIG. 16). During the engine's springcompression cycle--i.e., when fluid pressure is applied to engine 6 andbelt 12 is in a disengaged state--coupling sleeve 78 is driven to thedistal end of device 1. This movement causes tab 83 to slide parallel torail 85 in the direction indicated by arrow A (FIG. 18). Rail 85 ismounted on the inside surface of housing 3. Just before tab 83 clearsrail 85 (shown in phantom lines in FIG. 18), tab 83 engages elastic band86, which presses the tab against the rail. When the trailing end of tab83 clears the distal end of rail 85, the tab is forced by elastic band86 to rest against second post 87. The movement of tab 83 over to post87 causes the rotation of sleeve 78. Referring to FIG. 17, rotation ofsleeve 78 in the direction of arrow B causes toothed tabs 88 and 89 toengage drive belt 12. Drive belt 12 is thus temporarily coupled toengine 6. When the power stroke, as explained above, begins, sleeve 78moves in the proximal direction and belt 12 moves with it due to theengagement of toothed tabs 88 and 89. The movement of sleeve 78 issufficient to rotate needle 5 360° in one power stroke.

Referring again to FIG. 19, the proximal movement of coupling sleeve 78also causes tab 83 to slide parallel to rail 85 in the direction ofarrow C to the position shown in phantom lines. Pressure derived fromthe engagement of tabs 88 and 89 with belt 12 holds tab 83 against rail85. Before tab 83 clears rail 85, tab 83 once again engages elastic band86 which further presses tab 83 against rail 85. When the trailing endof tab 83 clears the proximal end of rail 85, the tab is forced over topost 84, where it comes to rest in its original position. As before,this action rotates coupling sleeve 78. However, now sleeve 78 rotatesin the opposite direction of arrow B in FIG. 17, releasing toothed tabs88 and 89 from drive belt 12 and uncoupling the belt from spring 69(FIG. 16).

Referring to FIGS. 16 and 17, contained within coupler 7 is a sled 90.The purpose of sled 90 is to reduce the drag on drive belt 12 againsthousing 3 by providing a lubricated sliding surface for the clampedbelt, as well as to provide a surface against which the belt can beclamped. Sled 90 is connected to coupling sleeve 78 by sled extensions91 and 92 which are positioned between tabs 88 and 89. A third extension90A, located between extensions 91 and 92, position sled 90 betweencoupling sleeve 78 and housing 3. When coupling sleeve 78 rotates, justprior to the engine's power stroke, tabs 88 and 89 clamp belt 12 to sled90. This allows belt 12 to travel with sled 90 as spring 69 is releasedfrom its compressed state. When drive belt 12 is unclamped, belt 12 isfree to slide through sled 90 as it passes through coupler 7.

Referring to FIGS. 13 and 14, full extension of spring 69 during theengine's power stroke is regulated by a clip 70 mounted on the distalend of connecting rod 71. Clip 70 engages a washer 72 which in turnengages the inside wall of the proximal end of engine housing 73. Clip70 ensures that all primary engine parts connected to rod 71 will returnto their predetermined starting positions, and that needle 5 will onlyrotate through a prescribed stroke distance. Washer 72, slideablymounted on connecting rod 71, acts as a buffer between the small surfacearea of clip 70 and the larger surface area of the proximal end ofengine housing 73. Washer 72 has the secondary function of removing anybiological debris from connecting rod 71 before it leaves engine housing73 so the debris does not enter engine 6 or coupler 7. The distal end ofconnecting rod 71 is slideably secured within passage 74, located at thedistal end of engine housing 73. This positions connecting rod 71 withinthe engine assembly. Engine housing 73 is designed with an aperture toprovide access to clip 70, connecting rod 71, and washer 72.

In order to provide greater flexibility in locating sutures with theinvention, a head articulation system is provided. This system will beexplained below with reference to FIGS. 1 and 7-11. As shown in FIG. 8,when head 2 is in a "resting" position, needle 5 lies in a plane angledat approximately 45° from the longitudinal axis of device 1. The"resting" position of head 2 allows the device to be inserted andremoved from a patient's body cavity through a cannula. However, withthe articulation system, the position of head 2 may be rotated about anyof the three axes (x, y and z, shown in FIG. 1). Thus, the position ofhead 2, and needle 5 therein, can be changed to accommodate almost anysuturing angle.

Two "timing" belts 45 and 59 are provided for controlling the movementof the head about the x and y axes. As shown in FIG. 11, in a preferredembodiment, both timing belts 45 and 59 are toothed on both sides. Thisprovides for positive engagement of belts 45 and 59 with sprocketedbases 46 and 60, respectively. It also provides a user of the devicewith a gripping surface on the outside of each belt. Alternatively,belts 45 and 59 can be provided with other gripping means including arough outer surface or slits. Another alternative, is to employ standardtiming belts 45 and 59 having teeth on the inside only. Belts 45 and 59can then be turned inside out beyond guiding channel 35B (FIG. 8) afterthe belts have exited head 2. The belt teeth will therefore be exposedto a user for gripping at the proximal end of the device.

As will be appreciated, head 2 can also be rotated about a longitudinalaxis passing through the center of suturing device 1 (the z-axis) simplyby rotating suturing device 1 within cannula 4. Alternatively, head 2can be mounted for independent rotation from device 1 about the z-axis.

Belt 45 controls rotation of head 2 about the x-axis, specifically anaxis passing through the center of rotation of axles 26 and 29 (FIG. 7).At the proximal end of the device, belt 45 is supported by pulley 44. Asbest shown in FIGS. 8 or 10, a sprocketed base 46 engages and supportsbelt 45 at the distal end of the device. Fixed to the top of base 46 isa worm gear 50 which, together with base 46, is rotationally mounted onpost 51. This assembly is held in place by a washer 52 and a circle clip53 which is received in groove 53A. Worm gear 50 meshes with a matingworm wheel 54 (FIG. 9), which is pivotally mounted on x-axis bearingextensions 56 and 57 by axles 26 and 29. Translational movement ofx-axis timing belt 45 thus rotates worm gear 50, which in turn engagesand rotates worm wheel 54 and finally rotates head 2 about the x-axis.

Similar to x-axis timing belt 45, timing belt 59 controls rotation ofhead 2 about the y-axis, specifically an axis passing through the centerof rotation of post 51, as shown in FIG. 8. Y-axis timing belt 59 isalso supported by a pulley 58 at the proximal end of device 1. At thedistal end of the device belt 59 engages and is supported by sprocketedbase 60. Sprocketed base 60 is fixed to bearing extensions 56 and 57(which are part of detent plate 49) and rotates around the y-axis onpost 51. Through this arrangement, translational movement of y-axistiming belt 59 is thus converted into rotational movement of head 2about the y-axis.

It should be noted that manipulation of belt 59 by itself will alsoaffect the position of head 2 about the x-axis. Thus, if articulation ofhead 2 is required only about the y-axis, with no change of positionabout the x-axis (i.e., the head has already been properly positionedabout the x-axis), then belts 45 and 59 should be operatedsimultaneously. This will allow head 2 to move about the y-axis withoutany change in the position of the head about the x-axis. Alternatively,means for articulating the head in more than one direction by a singlecontrol element is contemplated.

As best shown in FIG. 10, detent plate 49 is mounted on post 51, betweenthe post and sprocketed base 60. Small protrusions 47 on the bottom ofbase 46 are sequentially received in detents 48 located on the topsurface of detent plate 49. This provides a user with a tactile output,in the form of a "click," which allows the user to gauge the relativerotational movement between base 46 and plate 49 when head 2 is rotatedabout either the x-axis or y-axis.

In order to lock head 2 into position to prevent unwanted movement ofthe head as a suture is installed, an automatic locking system isprovided. Referring to FIGS. 14 and 15, protruding from the distal endof engine housing 73 is a follower 80 slideably mounted in groove 81formed on the inside surface of housing 3. Follower 80 is fixed toengine housing 73, or alternatively, is a separate piece butted upagainst engine housing 73. Whenever a sufficient amount of pressure ispresent within cylinder 65 (during either the spring compression cycleor the engine's power stroke) a force is imparted on follower 80 throughengine housing 73. This force secures the tip of follower 80 in betweencrests 82 formed on detent plate 49, and rigidly secures the position ofhead 2. By restricting movement of head 2, proper placement of a sutureis ensured.

As explained above, when at rest, the foot pedal assembly provides asmall pressure force to the engine. This force keeps follower 80 incontact with detent plate 49, but still allows the follower to ridecrests 82 on detent plate 49 when head 2 is articulated about they-axis. Sufficient clearance room is provided between the proximal endof piston 67 and cylinder opening 64 to allow follower 80 to ride crests82, as best illustrated in FIG. 13.

Referring to FIGS. 6-8 and 10, mounted to a front face 94 of saddle 13is a capstan-like post 95. Post 95 is separated from front face 94 by agap which allows thread 92 to pass therebetween while needle 5 rotateson saddle 13. Capstan-like post 95 has rounded edges which helps tosecure the pre-looped suture thread to head 2 during the suturingprocess, but also allows thread 92 to be easily removed from head 2 whena user is prepared to tie a knot to secure a suture. Located in the topportion of front face 94 is an aperture 91. Aperture 91 is utilized tolay up suture thread 92 before suturing. It allows a loop of thread 92to be drawn up the length of suturing device 1 so that some of thethread manipulation may be done outside the internal body cavity of apatient.

Preferably, surgical suturing device 1 is contained within a kit. Thiskit comprises a trocar and the surgical suturing device describedherein, configured and dimensioned to be inserted into the trocarcannula. The elements of the kit are immersed in a medically safelubricant which not only provides for easier movement of the mechanicalparts within suturing device 1, but also, eases insertion of thesuturing device into the trocar cannula.

The surgical suturing device described herein is equally well suited andadaptable for ligating a biological tube or duct. Referring to FIG. 5,needle 5 is simply passed around or through the tube or ductaccommodated in opening 16, after which, the resulting knot is secured.

Except as specifically noted, the various components of the presentinvention may be constructed from a variety of biocompatible materials,particularly plastics, the specific selection of which is well withinthe ability of a person of ordinary skill in the art.

I claim:
 1. An apparatus for suturing or ligating, comprising:a bodymember having first and second ends; at least two rotatable pulleysmounted within the body member; a flexible, continuous loop driveelement mounted on said pulleys for circulation therearound; meansmounted in the body member adjacent to the first end for circulating thecontinuous loop element; and an arcuate suturing needle mounted at thesecond end of the body member for 360° rotation through a closed path,said needle having a plurality of spaced projecting means for engagingthe continuous loop element over an included segment of the needle'souter perimeter.
 2. The apparatus of claim 1, wherein said projectingmeans are arranged on the needle such that at least two of saidprojecting means engage the continuous lop element at all times duringrotation of the needle.
 3. The apparatus of claim 1, further comprisingrotatable means for supporting the continuous loop drive elementadjacent to the first end, wherein said means for supporting extends atleast partially outside of the body member to allow direct manipulationof the drive element by a user, whereby positioning of the needle may becontrolled by hand.
 4. The apparatus of claim 1, wherein the arcuateneedle defines an arc having an included angle greater than 180°, andwherein said apparatus further comprises:a saddle member mounted at thesecond end having arcuate outer surface slideably mating with andreceived inside the arc of the arcuate needle, said outer surfacedefining an arc also having an included angle greater than 180°, saidsaddle member further defining an open throat area opposite said outersurface of the saddle in which material to be sutured is received; andmeans for tensioning said continuous loop drive element around thearcuate outer surface with the needle received therebetween such thatthe needle projecting means are maintained in engagement with thecontinuous loop drive element.
 5. The apparatus of claim 1 wherein saidcirculating means comprises:a reciprocating member slideably mountedwithin the housing for longitudinal movement therein; and means forcoupling said continuous loop element with the reciprocating memberduring movement of said member in a first longitudinal direction and foruncoupling said element from the reciprocating member during movement ina second opposite longitudinal direction.
 6. The apparatus of claim 5,wherein said coupling means comprises:a coupling sleeve engaging thereciprocating member for longitudinal movement therewith and beingfreely rotatable therearound; means projecting from the sleeve forengaging said continuous loop element; and means for rotating thecoupling sleeve (a) in a first rotational direction in response to saidlongitudinal movement of the reciprocating member in the secondlongitudinal direction whereby said means projecting from the sleeveengages the continuous loop element for movement in the firstlongitudinal direction and (b) in a second opposite rotational directionin response to longitudinal movement of the reciprocating member in thefirst longitudinal direction whereby said means projecting from thesleeve disengages the continuous loop element.
 7. The apparatus of claim5, wherein:said body member comprises an elongated housing and a headassembly pivotally mounted on the elongated housing at the second end,wherein the arcuate needle is mounted in the head assembly and said headassembly is capable of rotational movement independent from saidelongated housing; and said apparatus further comprises means forlocking the position of the head assembly, said locking meanscooperating with said circulating means to lock the head assembly duringsuturing or ligating procedures.
 8. The apparatus of claim 1, furthercomprising internal sealing means to prevent the escape of pressure froman internal body cavity during suturing or ligating procedures.
 9. Anapparatus for suturing or ligating, comprising:an elongated housingdefining a central longitudinal axis having first and second ends; acontinuous loop drive element mounted within the body member forcirculation therein; means mounted in the body member adjacent to thefirst end for circulating the continuous loop element; and an arcuatesuturing needle mounted at the second end of the body member for 360°rotation through a closed path, said needle having a plurality of spacedprojecting means for engaging the continuous loop element over anincluded segment of the needle's outer perimeter; and a head assemblypivotally mounted on the elongated housing at the second end, whereinthe arcuate needle is mounted in the head assembly and said headassembly is capable of rotational movement independent from saidelongated housing and around at least one axis disposed at an angle tothe longitudinal axis.
 10. The apparatus of claim 9, further comprisingmeans for articulating said head assembly independently from saidelongated housing, said means for articulating comprising at least oneelongated drive element rotatably mounted within said housing and beingmanipulable at the first end of the housing.
 11. The apparatus of claim10, wherein said means for articulating the head assembly furthercomprises:pulley means for supporting the elongated drive element at thesecond end, said pulley means being rotatable about a second axistransverse to the longitudinal axis in response to manipulation of thedrive element at the first end; a worm gear mounted at the second end ofthe housing for rotation with said pulley means; and a worm wheelcomprising a portion of the head assembly mounted for rotation around athird transverse axis and cooperating with the worm gear, wherebymanipulation of the drive element causes the head assembly to pivotaround said third axis due to said cooperation of the worm gear and wormwheel.
 12. The apparatus of claim 10, wherein said means forarticulating the head assembly further comprises:pulley means forsupporting the elongated drive element at the second end, said pulleymeans being rotatable about a second axis transverse to the longitudinalaxis in response to manipulation of the drive element at the first end;and a bracket member mounted at the second end for rotation with saidpulley means, the head assembly being carried by said bracket member,whereby manipulation of the drive element causes the head assembly topivot around said second axis.
 13. An apparatus for suturing orligating, comprising:an elongated housing defining a first longitudinalaxis and having first and second ends; a head assembly pivotally mountedat the second end of the housing, said head being capable of pivotingabout second and third axes independently from the elongated housing; acontinuous loop drive element mounted within the housing and said headassembly for circulation therethrough; an arcuate needle mounted withinthe head assembly for 360° rotation in a closed path, said needle havinga plurality of spaced projecting means for engaging said continuouselement; means for articulating the head assembly independently aboutthe second or third axes independently from said elongated housing;means for circulating the continuous loop drive element.
 14. Theapparatus of claim 13, wherein said means for pivoting the head assemblycomprises:a first elongated drive element rotatably mounted within saidhousing and being manipulable at the first end of the housing; firstpulley means for supporting the first elongated drive element at thesecond end, said pulley means being rotatable about a second axistransverse to the longitudinal axis in response to manipulation of thefirst drive element at the first end; a bracket member mounted at thesecond end for rotation with said pulley means, the head assembly beingcarried by said bracket member, whereby manipulation of the first driveelement causes the head assembly to pivot around said second axis; asecond elongated drive element rotatably mounted within said housing andalso being manipulable at the first end of the housing; second pulleymeans for supporting the second elongated drive element at the secondend, said second pulley means also being rotatable about the second axisin response to manipulation of the second drive element at the firstend; a worm gear mounted at the second end of the housing for rotationwith said second pulley means; and a worm wheel comprising a portion ofthe head assembly mounted for rotation around a third transverse axisand cooperating with the worm gear, whereby manipulation of the seconddrive element causes the head assembly to pivot around said third axisdue to said cooperation of the worm gear and worm wheel.
 15. Theapparatus of claim 13 wherein, said means for circulating the continuousloop drive element further comprises:a reciprocating member slideablymounted within the housing for longitudinal movement therein; biasingmeans cooperating with an end of the reciprocating member for biasingsaid member in a first direction; cylinder means cooperating with theopposite end of the reciprocating member for forcing said member in asecond direction against said biasing means; means for actuating andde-actuating said cylinder means; and means for coupling said continuousloop element with the reciprocating member during movement of saidmember in the first longitudinal direction and for uncoupling saidelement during movement in the second opposite longitudinal direction.16. An apparatus for suturing or ligating, comprising:a body memberhaving first and second ends; a continuous loop drive element mountedwithin the body member for circulation therein; rotatable means forsupporting the continuous loop drive element wherein said rotatablemeans is carried by a longitudinally sliding member within the housing,said sliding member being biased in the direction of the first end tomaintain tension in the continuous loop drive element, and saidcontinuous loop drive element is manipulable at the first end of thehousing; means mounted in the body member adjacent to the first end forcirculating the continuous loop element; and an arcuate suturing needlemounted at the second end of the body member for 360° rotation through aclosed path, said needle having a plurality of spaced projecting meansfor engaging the continuous loop element over an included segment of theneedle's outer perimeter.
 17. A mechanical apparatus for suturing tissueor ligating a biological tube or duct, comprising:an elongated housing,defining a first longitudinal axis and having first and second ends; ahead assembly pivotally mounted at the second end of the housing, saidhead being capable of pivoting about second and third axes independentlyfrom the elongated housing; a continuous loop drive element mountedwithin the housing and head assembly for circulation therethrough; anarcuate needle mounted within the head assembly for 360° rotationthrough a closed path, said needle defining an arc having an includedangle greater than 180°, and having a plurality of closely spacedprojecting means for engaging the continuous loop drive element, saidprojecting means arranged on the needle such that at least two of saidprojecting means engage the continuous loop element at all times duringrotation of the needle; a saddle member mounted at the second end of thehousing having an arcuate outer surface slideably mating with andreceived inside the arc of the arcuate needle, said outer surfacedefining an arc having an included angle greater than 180°, said saddlemember further defining an open throat area opposite said outer surfaceof the saddle in which material to be sutured is received; means fortensioning said continuous loop drive element around the arcuate outersurface of said saddle member with said needle received therebetweensuch that the needle projecting means are maintained in engagement withthe continuous loop drive element; means for articulating the headassembly independently about the second or third axes, said meanscomprising; a first elongated drive element rotatably mounted withinsaid housing and being manipulable at the first end of the housing,first pulley means for supporting the first elongated drive element atthe second end, said pulley means being rotatable about a second axistransverse to the longitudinal axis in response to manipulation of thefirst drive element at the first end, a bracket member mounted at thesecond end for rotation with said pulley means, the head assembly beingcarried by said bracket member, whereby manipulation of the driveelement causes the head assembly to pivot around said second axis, and asecond elongated drive element rotatably mounted within said housing andalso being manipulable at the first end of the housing, second pulleymeans for supporting the second elongated drive element at the secondend, said second pulley means also being rotatable about the second axisin response to manipulation of the second drive element at the firstend, a worm gear mounted at the second end of the housing for rotationwith said second pulley means, and a worm wheel comprising a portion ofthe head assembly mounted for rotation around a third transverse axisand cooperating with the worm gear, whereby manipulation of the seconddrive element causes the head assembly to pivot around said third axisdue to said cooperation of the worm gear and worm wheel; means forcirculating the continuous loop drive element, said means comprising areciprocating member slideably mounted within the housing forlongitudinal movement therein, a coupling sleeve engaging thereciprocating member for longitudinal movement therewith and beingfreely rotatable therearound, means projecting from the sleeve forengaging said continuous loop drive element, and means for rotating thecoupling sleeve (a) in a first rotational direction in response to saidlongitudinal movement in the second longitudinal direction whereby saidmeans projecting from the sleeve engages the continuous loop elementduring movement in the first longitudinal direction and (b) in a secondopposite rotational direction in response to longitudinal movement ofthe reciprocating member in the first longitudinal direction wherebysaid means projecting from the sleeve disengages the continuous loopelement during movement in the second longitudinal direction; and meansfor locking the position of the head assembly during suturing orligating procedures.
 18. A kit for suturing tissue or ligating a tube orduct within a body cavity, comprising:a cannula adapted to be insertedthrough the body wall and communicate with the cavity; and a mechanicalapparatus for suturing or ligating configured and dimensioned to beslidingly received in said cannula in a gas-tight manner, said apparatuscomprisingan elongated housing having first and second ends and a headassembly pivotally mounted on the elongated housing at the second end,wherein said head assembly is capable of articulation ;independent fromsaid elongated housing and is articulable from a position outside thecannula at the first end of the elongated housing; a continuous loopdrive element mounted within the body member for circulation therein;means for circulating the continuous loop element; andan arcuate needlemounted for rotation within the head assembly having a plurality ofspaced projecting means for engaging the continuous loop drive element.19. The kit of claim 18, wherein the apparatus for suturing or ligatingfurther comprises rotatable means for supporting the continuous loopdrive element adjacent to the first end, said means extending at leastpartially outside of the elongated housing to allow direct manipulationof the drive element by a user, whereby positioning of the needle may becontrolled by hand from a position outside the cannula adjacent to thefirst end.
 20. The kit of claim 18, wherein the apparatus for suturingor agating further comprises internal sealing means to prevent theescape of pressure from an internal body cavity during suturing orligating procedures.
 21. A kit for suturing or ligating, including incombination:a trocar comprising a cannula having a length and a styletadapted to be slideably received in the cannula and extend beyond thecannula, said cannula having sealing means for providing a gas-tightseal around said stylet when received in the cannula; and a mechanicalsuturing apparatus, comprising an elongated housing defining a firstlongitudinal axis and having first and second ends, a head assemblypivotally mounted at the second end of the housing, said head beingcapable of pivoting about second and third axes independently from theelongated housing, wherein the housing and head assembly are configuredand dimensioned to be slidingly received in the cannula and togetherhave a length greater than said cannula length, a continuous loop driveelement mounted within the housing and head assembly for circulationtherethrough, an arcuate needle mounted within the head assembly for360° rotation in a closed path, said needle having a plurality of spacedprojecting means for engaging said continuous loop drive element, meansmanipulable by hand when the housing and head assembly are received inthe cannula for pivoting the head assembly about the second or thirdaxes independently from said elongated housing, and means forcirculating the continuous loop drive element.